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StuDy AimED at Increasing AlCohol AbsTinEnce
Sponsor: University of Illinois at Chicago
Summary
The goal of this clinical trial is to test the feasibility \& acceptability of an integrated CM-PST intervention (in K99 phase) and preliminary efficacy (in R00 phase), vs. CM alone, to improve treatment efficacy and inform about neural mechanisms of treatment effects in young adults with Alcohol Use Disorder (AUD). The aims are as follows: K99 Aim: Test feasibility \& acceptability of a developed CM-PST, by meeting these benchmarks: 2a Feasibility: enroll 20 participants in the new CM-PST in a single-arm pre- and post-study, and retain ≥85% at wk 12. 2b Deliver CM-PST at ≥90% fidelity to intervention protocol. 2c Acceptability to participants: Achieve mean score ≥3 on Client Satisfaction Scale Questionnaire and satisfaction from semi-structured interviews. R00 Aim 1) Test preliminary efficacy of CM-PST in a 2-arm pilot RCT: Male/female young adults (aged18-24) who meet AUD criteria will be randomized to CM-PST or CM-only control, and assessed at baseline (0), 3, and 6 months. Primary study endpoint will be 3 months. R00 Aim 2 (Exploratory) Explore potential neural mechanisms of CM-PST effects, by fMRI scanning \& analyses of core regions of the brain circuits regulating positive affect (ventral striatum), negative affect (amygdala), and cognitive control (dorsolateral prefrontal cortex), and connectivity between these core regions.
Official title: StuDy AimED at Increasing AlCohol AbsTinEnce (DEDICATE)
Key Details
Gender
All
Age Range
18 Years - 24 Years
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2023-07-30
Completion Date
2028-05-31
Last Updated
2025-04-03
Healthy Volunteers
Yes
Conditions
Interventions
CM-PST
CM-PST is a tailored behavioral intervention that enables young adults with AUD to successfully manage and overcome everyday life challenges influencing their alcohol intake.
CM only
CM is a behavior therapy that rewards individuals for evidence of positive change (alcohol abstinence).
Locations (1)
University of Illinois at Chicago
Chicago, Illinois, United States